Identity
- Trade Name
- SLM FDA UDI
- Generic Name
- Mechanical pipette FDA UDI
- Device Name
- ICSI Injection Pipette FDA UDI
- Model / Reference
- SIC-55W-30L FDA UDI
- Description
- ICSI Injection Pipette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816633021674 FDA UDI
- 510(k) Number
- K072600 FDA UDI
- FDA Product Code
- PUC FDA UDI
- GMDN Term
- Mechanical pipette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Mechanical pipette
The SLM ICSI Injection Pipette is a manually-operated, specially designed device for the precise and efficient transfer of discrete volumes of fluid materials in laboratory settings. Featuring a unique internal mechanism powered by finger movement, this pipette is ideal for obstetrics/gynecology professionals who require accurate and consistent volume delivery.
Similar devices
Also classified as Mechanical pipette.
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- LabChoice Mechanical Pipette, Single Channel, Adjustable Volume 0.5 - 5 ML — Dynarex Corp. · Class I
- Sunbiotec — Hubei Huamei Sunlight Biotechnologies Co., Ltd · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K072600 also covers:
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunlight Medical, Inc.
Sources (1)
- FDA UDI fd0e9310-830a-40dd-994d-36a33ec26bf1 35 fields · synced Jul 3, 2026